Phage display‐based molecular methods in immunohematology

Abstract

The goal of the current Food and Drug Administration-sponsored workshop was to explore the feasibility of utilizing newly developed molecular approaches in the area of immunohematology. As stated by the workshop’s organizers, conventional methods for blood grouping and associated compatibility testing have served us well for many decades, yet blood incompatibility remains a significant problem in transfusion medicine. This is due, in part, to the variability in the performance characteristics of preparations of polyclonal or monoclonal antibody reagents as well as to certain inherent limitations in a detection scheme that is agglutination-based. Furthermore, in comparison with diagnostic testing performed in other areas of laboratory medicine, current pretransfusion-testing methods are extraordinarily labor-intensive, an order of magnitude more expensive, subjective with respect to the interpretation of assay results, and tend to defy the development of high-throughput automation. Another drawback, as expressed by the Food and Drug Administration, is that current blood bank testing is a “single ‘analyte’ per test kind of test,” in other words, one antibody/agglutination result per tube. The ability to get more than one result per test, that is, “multiplexing” blood